Wheeled Knee Walker for Diabetic Foot

Overseen By Audrey R Zucker-Levin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Must not be taking: Balance impairing drugs

Disqualifiers: Coronary disease, Severe conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

68 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if your medications cause impaired balance or judgment, you may not be eligible to participate.

What data supports the effectiveness of the Wheeled Knee Walker treatment for diabetic foot?

The Wheeled Knee Walker is shown to be a satisfactory assistive device for people recovering from foot or ankle surgery, with most users reporting satisfaction despite some experiencing falls. This suggests it may be a helpful tool for mobility and potentially beneficial for diabetic foot care by reducing weight-bearing stress, similar to other offloading devices used for diabetic foot ulcers. ^{1 2 3 4 5}

Is the Wheeled Knee Walker safe for use?

In a study of people using the Wheeled Knee Walker after foot or ankle surgery, 43% of participants experienced falls, with many having multiple falls. Despite this, most users were satisfied with the device. ^{2 3 4 6 7}

How is the Wheeled Knee Walker treatment different from other treatments for diabetic foot?

The Wheeled Knee Walker (WKW) is unique because it provides a non-weightbearing way to move around, which can help protect and heal diabetic foot ulcers by reducing stress on the foot. Unlike traditional crutches or removable cast walkers, the WKW allows for easier mobility and may be more comfortable, although it requires proper instruction to prevent falls. ^{2 3 4 8 9}

What is the purpose of this trial?

The increasing incidence of diabetes and high risk of amputation makes prevention and successful treatment of DFU of vital importance. A relatively new device, the wheeled knee walker, allows total offloading of the affected foot and, when compared to traditional walking aids such as crutches and walkers, requires significantly less physical exertion, is easier to use, and affords more stability. Its potential benefit to improve wound healing, impact physical function and quality of life in people with DFU is not yet known. Therefore, the goal of this research is to determine whether providing a wheeled knee walker to people with diabetic foot ulcers improves clinical outcomes and quality of life when compared to usual and customary care.

Research Team

Audrey R Zucker-Levin, PhD

Principal Investigator

University of Saskatchewan

Eligibility Criteria

This trial is for individuals with diabetes and a specific type of foot ulcer (grade 1A). Participants must be under a doctor's care, weigh no more than 300lbs, be over 18 years old, mentally capable, have phone access, and at least one palpable foot pulse. Excluded are those with active infections or severe health conditions like heart failure or recent strokes.

Inclusion Criteria

currently under physician care for a DFU of one foot

willing and able to sign informed consent

weigh no more than 300lbs as this is the weight limitation of the wheeled knee walker

Exclusion Criteria

active infection

uncontrolled, severe medical conditions that place the subject at high risk for adverse events, including but not limited to severe congestive heart failure, angina pectoris, obstructive pulmonary disease

You have experienced a heart or brain-related medical event within the past six months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Standardized baseline measures for each objective are performed

1 week

Treatment

Participants receive usual and customary care, with half receiving a wheeled knee walker

12 weeks

Re-evaluation at 6 and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Wheeled Knee Walker

Trial Overview The study tests if using a wheeled knee walker aids healing in diabetic foot ulcers compared to usual care. It aims to see if this device can improve wound healing and quality of life by allowing total offloading of the affected foot while being easier to use than crutches.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

The Intervention Group will receive usual and customary care from their vascular specialist and they will be provided and trained to use the wheeled knee walker.

Group II: Control group Active Control 1 Intervention

The Control Group will receive usual and customary care from their vascular specialist.

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Saskatchewan Health Research Foundation

Collaborator

Trials

33

Recruited

5,100+

Findings from Research

In a study of 57 patients with diabetes-related foot ulcers, the average adherence to using knee-high removable cast walkers (RCWs) was only 33.6% of the prescribed weight-bearing activity, indicating a significant challenge in treatment compliance.

Factors associated with lower adherence included being male, having a longer duration of diabetes, not having peripheral artery disease, and perceiving the RCW as heavy, suggesting that these characteristics should be considered when prescribing offloading treatments to improve patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with adherence to using removable cast walker treatment among patients with diabetes-related foot ulcers. Ababneh, A., Finlayson, K., Edwards, H., et al.[2022]

In a study of 80 patients using wheeled knee walkers after foot or ankle surgery, 43% reported experiencing falls, with many of those individuals (62%) experiencing multiple falls, highlighting a significant safety concern.

Despite the high rate of falls, 91% of respondents expressed satisfaction with the knee walker, indicating that patients may value the mobility it provides even when safety issues arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Wheeled Knee Walker Use following Foot and Ankle Surgery or Injury. Yeoh, JC., Ruta, DJ., Murphy, GA., et al.[2022]

In a study involving 24 healthy volunteers, the wheeled knee walker was found to allow for better assisted ambulation compared to axillary crutches, as indicated by significant improvements in walking distance and self-selected walking velocity during a 6-minute walk test.

Participants reported a lower perceived exertion when using the wheeled knee walker, with 88% preferring it over crutches, suggesting it may be a more comfortable option for rehabilitation after lower extremity surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Assisted Ambulation and Perceived Exertion With the Wheeled Knee Walker and Axillary Crutches in Healthy Subjects. Kocher, BK., Chalupa, RL., Lopez, DM., et al.[2017]

In a study involving 11 diabetic subjects, ankle-high walkers provided similar offloading capacity for diabetic foot ulcers as knee-high walkers, suggesting they may be a more comfortable and stable option.

All walker types outperformed athletic shoes in reducing peak pressure on the foot, indicating that offloading is crucial for ulcer healing, and the lighter ankle-high walker may improve patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of strut height on offloading capacity of removable cast walkers. Crews, RT., Sayeed, F., Najafi, B.[2021]

Patients with diabetes-related foot ulcers showed significantly higher adherence to using knee-high removable cast walkers (RCWs) during the daytime (39.9%) compared to nighttime (20.4%), indicating a critical difference in adherence based on time of day.

Factors influencing lower adherence included being male, longer diabetes duration, and higher perceived heaviness of the RCW during the day, while nighttime adherence was affected by higher daytime activity levels and the presence of certain health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in adherence to using removable cast walker treatment during daytime and nighttime weight-bearing activities in people with diabetes-related foot ulcers. Ababneh, A., Finlayson, K., Edwards, H., et al.[2023]

Using a wheeled walker (WW) significantly slowed down older patients when passing through doors, taking an average of 12.86 seconds compared to 8.71 seconds without the walker, indicating usability challenges in tight spaces.

Most users reported difficulties with uphill (77%) and downhill (83%) walking, as well as crossing obstacles (77%), highlighting key areas for improvement in the design of intelligent WWs to enhance mobility and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problems of older persons using a wheeled walker. Lindemann, U., Schwenk, M., Klenk, J., et al.[2022]

Participants with diabetic foot ulcers (DFUs) found the smart removable walker (smart boot) easy to use and reported a strong preference for it, especially among Hispanic or Latino users, indicating that user-friendly designs can enhance adherence to treatment.

Non-fallers expressed a greater desire to wear the smart boot longer and found it easier to manage, suggesting that addressing user experience and comfort can improve compliance with offloading devices for ulcer healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model. Finco, MG., Cay, G., Lee, M., et al.[2023]

The study involving 25 individuals at risk for diabetic foot ulcers found that ankle-high removable cast walkers (RCWs) combined with a contralateral limb lift improved comfort and gait, which may enhance patient adherence to offloading treatments.

While knee-high RCWs provided better offloading of the foot, they were less comfortable and resulted in slower walking speeds, suggesting that comfort is crucial for encouraging patients to consistently use offloading devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing an Offloading Device's Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to Improved Comfort and Gait. Crews, RT., Candela, J.[2019]

Patients using a front-wheeled walker after total knee replacement (TKR) surgery demonstrated faster walking velocity and longer step lengths immediately after surgery compared to those using a standard walker, indicating a potential short-term benefit in mobility.

However, by six weeks post-surgery, both walker groups showed similar improvements in walking speed and endurance, suggesting that while the wheeled walker may aid initial recovery, it does not lead to greater long-term ambulation benefits or reduced therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. Pasquini, SM., Peterson, ML., Rattansi, SM., et al.[2010]

References

1. England pubmed.ncbi.nlm.nih.gov

Factors associated with adherence to using removable cast walker treatment among patients with diabetes-related foot ulcers. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Analysis of Wheeled Knee Walker Use following Foot and Ankle Surgery or Injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative Study of Assisted Ambulation and Perceived Exertion With the Wheeled Knee Walker and Axillary Crutches in Healthy Subjects. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Impact of strut height on offloading capacity of removable cast walkers. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Differences in adherence to using removable cast walker treatment during daytime and nighttime weight-bearing activities in people with diabetes-related foot ulcers. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Problems of older persons using a wheeled walker. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Decreasing an Offloading Device's Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to Improved Comfort and Gait. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. [2010]